Pharmacists Regulations 1991 (SA)

Case

South Australia

Pharmacists Regulations 1991

under the Pharmacists Act 1991

Contents

Part 1—Preliminary

  1. Short title

  2. Revocation

  3. Interpretation

  4. Fees

Part 2—Registration of pharmacists

  1. Eligibility for registration

  2. Exemption from obligation to be registered in case of death or bankruptcy etc

  3. Other exemptions

  4. Prescribed additional qualifications

  5. Name of registered company

Part 3—Practice of pharmacy

Division 1—General

  1. Prohibition on use of certain words

  2. Business or trading names

  3. Information relating to claim against pharmacist to be provided

  4. Information as to incapacity

Division 2—Premises and reference works

  1. Standard of premises

  2. Access to registered premises

  3. Reference works

  4. Ceasing to practise pharmacy at registered premises

  5. Other businesses not to be carried on at registered premises

Division 3—Prescription items

  1. Prescription received by facsimile

  2. Expired prescription

  3. Suspected forgeries etc

  4. Labelling of dispensed item

  5. Marking of prescription

  6. Records of prescriptions

  7. Delivery of dispensed items

  8. Non-derogation from Controlled Substances Act 1984

Division 4—Advertising

  1. Advertising by pharmacists

Schedule 1—Qualifications

Part 1—Qualifications from Australia or New Zealand

Part 2—Qualifications from Ireland or Great Britain

Schedule 2—Forms

Legislative history

Appendix—Divisional penalties and expiation fees

Part 1—Preliminary

1—Short title

These regulations may be cited as the Pharmacists Regulations 1991.1

Note—

1These regulations will come into operation on the day that the Pharmacists Act 1991 comes into operation.

2—Revocation

All regulations previously made under the Pharmacy Act 1935 are revoked.

3—Interpretation

In these regulations, unless the contrary intention appears—

the Act means the Pharmacists Act 1991;

approved pharmacist means—

(a)a registered pharmacist (other than a person who has limited or provisional registration); or

(b)a person unconditionally registered as a pharmacist, or otherwise unconditionally authorised to practise pharmacy, under the law of another State, or a Territory, of the Commonwealth or under the law of New Zealand;

first aid course means—

(a)the senior first aid certificate course conducted by St. John Ambulance Australia—South Australia Inc.; or

(b)the senior first aid certificate course conducted by Australian Red Cross Society South Australian Division; or

(c)a course in first aid that is, in the opinion of the Board, of equivalent standard to a course referred to above;

forensic examination means a multiple choice examination conducted by the Board on the law applying in this State in relation to the sale or supply of poisons and other pharmaceutical items.

Note—

For definition of divisional penalties (and divisional expiation fees) see Appendix.

4—Fees

  1. The Board may fix fees or charges for the following:

    (a)registration of pharmacists (including provisional or limited);

    (b)renewal of registration of pharmacists;

    (c)entering in the register any new or additional qualifications;

    (d)issue of duplicate registration certificate;

    (e)preparation of statements verifying registration;

    (f)other extracts from register;

    (g)inspection of register;

    (h)approval of company, trading or business name;

    (i)approval of alteration of memorandum and articles of association of company;

    (j)registration of premises;

    (k)renewal of registration of premises;

    (l)other authorisations or approvals under the Act or these regulations.

  2. Fees for registration or renewal of registration may vary according to whether the applicant is a natural person or a company, and in the case of a company, may vary according to whether or not the memorandum and articles of association of the company are in a standard form approved by the Board.

  3. The Board may recover a fee or a charge as a debt.

Part 2—Registration of pharmacists

5—Eligibility for registration

An applicant for registration under the Act must have the following qualifications and experience and fulfil the following requirements:

(a)—

(i)a degree or diploma in pharmacy granted or conferred by a University, College or Institute in Australia or in New Zealand listed in Part 1 of Schedule 1; and

(ii)satisfactory completion of a period of practical experience in pharmacy under the supervision of an approved pharmacist of at least one year or such lesser period as the Board determines having regard to post-graduate academic qualifications held by the applicant; and

(iii)satisfactory completion of a first aid course and a forensic examination; or

(b)unconditional registration as a pharmacist, or other unconditional authorisation to practise as a pharmacist, under the law of another State, or a Territory, of the Commonwealth or under the law of New Zealand; or

(c)—

(i)a degree or diploma in pharmacy granted or conferred by a University, College, Institute or other body in Ireland, Northern Ireland or Great Britain listed in Part 2 of Schedule 1; and

(ii)unconditional registration as a pharmacist, or other unconditional authorisation to practise as a pharmacist, under the laws of at least one of those countries; and

(iii)satisfactory completion of at least 4 weeks of practical experience in pharmacy under the supervision of an approved pharmacist; and

(iv)satisfactory completion of a first aid course and a forensic examination; or

(d)—

(i)a certificate granted by the Australian Pharmacy Examining Council certifying that the person has the necessary qualifications to practise pharmacy in this State; and

(ii)satisfactory completion of at least the period recommended or required by the Australian Pharmacy Examining Council of practical experience in pharmacy under the supervision of an approved pharmacist; and

(iii)where an applicant has obtained his or her qualifications in pharmacy in a non-English speaking country, the applicant must satisfy the Board that the applicant has sufficient knowledge of the English language with which to carry on the practice of pharmacy; and

(iv)satisfactory completion of a first aid course and forensic examination.

6—Exemption from obligation to be registered in case of death or bankruptcy etc

  1. The personal representative of a deceased registered pharmacist may carry on the practice of the deceased pharmacist for a period not exceeding 1 year (or such longer period as the Board may allow) from the date of death.

  2. The trustee in bankruptcy of a registered pharmacist may carry on the practice of the pharmacist for a period not exceeding 1 year, or such longer period as the Board may allow.

  3. A receiver or liquidator appointed in respect of a company that is a registered pharmacist may carry on the practice of the company for a period not exceeding 1 year, or such longer period as the Board may allow.

  4. A person who exercises rights in pursuance of this section (otherwise than with the prior permission of the Board) must, within 7 days after commencing to do so, give notice in writing of that fact to the Board.

    Penalty: Division 7 fine.

7—Other exemptions

Section 26 of the Act does not apply to—

(a)a person who has obtained academic qualifications in pharmacy and who is undergoing a period of experience under the supervision of an approved pharmacist with a view to applying for registration as a pharmacist and has obtained the approval of the Board to do so;

(b)The Little Company of Mary SA Inc. the extent that it carries on the practice of pharmacy at Calvary Hospital, North Adelaide.

8—Prescribed additional qualifications

For the purposes of section 24 of the Act, the following qualifications must be entered on the register at the request of a registered pharmacist:

(a)any University degree or diploma relating to the practice of pharmacy;

(b)any degree, diploma or other qualification in a medical or health field awarded by an educational institution;

(c)membership of any association that has objects relating to pharmacy and that is established in any State or Territory of the Commonwealth or in New Zealand.

9—Name of registered company

The name of a company that is to be registered as a pharmacist must be approved by the Board.

Part 3—Practice of pharmacy

Division 1—General

10—Prohibition on use of certain words

For the purposes of section 28 of the Act, "druggist" is a prescribed word.

11—Business or trading names

A person must not practise pharmacy under a business or trading name unless that name has been approved by the Board.

Penalty: Division 7 fine.

12—Information relating to claim against pharmacist to be provided

For the purposes of section 31 of the Act, the information that must be provided to the Board relating to a claim for damages or compensation from a registered pharmacist for alleged negligence committed in the course of practice as a pharmacist is as follows:

(a)full details of the alleged negligence, including the nature of the procedure that is alleged to have been carried out negligently and the place, and the time and date, at which it is alleged to have occurred; and

(b)details of any injury or loss suffered or allegedly suffered by any person as a result of the alleged negligence; and

(c)details of any court judgment or order made in respect of the claim, including any amount ordered to be paid by the pharmacist by way of damages or compensation; and

(c)details of any agreement entered into to pay a sum of money in settlement of the claim, including the amount agreed to be paid.

13—Information as to incapacity

For the purposes of section 42(c) of the Act, a report submitted to the Board by a medical practitioner relating to the incapacity of a pharmacist must contain the following information:

(a)the diagnosis of the pharmacist's illness;

(b)the prognosis (including the likely duration) of the pharmacist's illness;

(c)a description of any treatment being received by the pharmacist for any mental or physical illness or disability;

(d)a description of any form of pharmacy that the pharmacist is not in the opinion of the medical practitioner fit to provide.

Division 2—Premises and reference works

14—Standard of premises

  1. Premises at which a business consisting of or involving pharmacy is carried on must, unless the Board otherwise approves under this regulation—

    (a)consist of an enclosed area with access to a public place;

    (b)contain an area set aside for the dispensing of items on prescription that is not less than 9 square metres;

    (c)be in a hygienic condition and be adequately ventilated;

    (d)have provision for adequate lighting;

    (e)contain adequate provision for the secure and hygienic storage of drugs and pharmaceutical products;

    (f)be constructed in such a manner as to allow a pharmacist to supervise effectively the whole of that part of the premises used in the practice of pharmacy and the activities of persons in that part of the premises.

  2. The Board may approve premises that do not comply with subregulation (1) (and register the premises under section 32 of the Act) if satisfied—

    (a)that the premises are used as a delivery and collection point for drugs, medicines or other pharmaceutical products that have been pre-packaged for specific customers outside Metropolitan Adelaide (as defined in the Development Plan) and are not otherwise used in the practice of pharmacy; and

    (b)that an adequate pharmaceutical service cannot otherwise be provided in the locality.

  3. Premises at which a business consisting of or involving pharmacy is carried on must be kept, at all times, in a hygienic and tidy condition.

  4. A person who carries on a business of or involving the practice of pharmacy at premises that do not comply with subregulation (3) is guilty of an offence.

    Penalty: Division 7 fine.

15—Access to registered premises

A person who carries on a business consisting of or involving pharmacy at registered premises must ensure that the name and phone number of a pharmacist who can, at all times, gain ready access to the premises is displayed at the entrance to the premises.

Penalty: Division 7 fine.

16—Reference works

  1. Current editions of the following reference works must be kept at any premises at which pharmacy is practised:

    (a)Martindale's Extra Pharmacopoeia;

    (b)Australian Pharmaceutical Formulary and Handbook;

    (c)the Prescriptions Proprietaries Guide or Mims Annual;

    (d)a reference work on therapeutics.

  2. Copies of the following Acts, regulations and Standards as in force from time to time must be kept at any premises at which pharmacy is practised:

    (a)the Act and these regulations;

    (b)the Controlled Substances Act 1984 and all regulations made under that Act that are relevant to the practice of pharmacy;

    (c)the Standard for the Uniform Scheduling of Drugs and Poisons published by the National Health and Medical Research Council.

  3. It is sufficient for the purposes of this regulation if the required reference work, Act, regulation or Standard is stored by computer, microfilm or other process and is readily accessible.

  4. If the requirements of this regulation are not complied with, the person who carries on the business consisting of or involving pharmacy at the premises is guilty of an offence.

    Penalty: Division 7 fine.

17—Ceasing to practise pharmacy at registered premises

A person must, within 7 days after ceasing to carry on a business of or involving the practice of pharmacy at registered premises, give written notice of that fact to the Registrar.

Penalty: Division 8 fine.

18—Other businesses not to be carried on at registered premises

  1. A person must not, without the approval of the Board, carry on a business other than the practice of pharmacy, or a business commonly associated with the practice of pharmacy, at registered premises.

    Penalty: Division 7 fine.

  2. A person must not carry on a business commonly associated with the practice of pharmacy at registered premises unless—

    (a)the person is the person in whose name the premises are registered; or

    (b)the approval of the Board has been obtained.

    Penalty: Division 7 fine.

Division 3—Prescription items

19—Prescription received by facsimile

A pharmacist must not dispense an item on a prescription received by means of a facsimile machine or other electronic or photographic means unless he or she has first verified the authenticity of the prescription.

Penalty: Division 7 fine.

20—Expired prescription

A pharmacist must not dispense an item on prescription more than one year after the date of the issue of the prescription.

Penalty: Division 7 fine.

21—Suspected forgeries etc

  1. A pharmacist must not dispense an item on prescription if there are reasonable grounds for suspecting that the prescription has been altered, forged or obtained on false pretences.

    Penalty: Division 7 fine.

  2. It is a defence to a charge of an offence against this regulation if it is proved that the offence did not result from any failure on the part of the defendant to take reasonable care to avoid the commission of the offence.

22—Labelling of dispensed item

  1. Each item dispensed on a prescription must be labelled with—

    (a)the name (or approved business or trading name), address and telephone number of the person carrying on the practice of pharmacy at the premises at which the item is dispensed; and

    (b)the name of the person for whose use the item is dispensed; and

    (c)the trade name and the generic name of the item dispensed, or, if it does not have either a trade or generic name, its ingredients; and

    (d)adequate directions for the safe and proper use of the item; and

    (e)a unique identifier enabling the item to be linked with the prescription; and

    (f)the date on which the item is dispensed.

  2. A pharmacist who dispenses an item on prescription that is not labelled in accordance with this regulation is guilty of an offence.

    Penalty: Division 7 fine.

23—Marking of prescription

  1. Each prescription on which an item is dispensed by a pharmacist must be marked with the following:

    (a)the unique identifier applicable to the item;

    (b)the name (or approved business or trading name), address and telephone number of the person carrying on the practice of pharmacy at the premises at which the item is dispensed.

  2. If a prescription has been issued in duplicate, it is sufficient compliance with this regulation if the required information is marked on the duplicate prescription.

  3. If a prescription is not marked in accordance with this regulation, the pharmacist who dispensed the prescription is guilty of an offence.

    Penalty: Division 7 fine.

24—Records of prescriptions

  1. A person who carries on a business consisting of or involving pharmacy must keep an accurate record of each prescription on which an item is dispensed in the course of that business, together with the following details:

    (a)the unique identifier applicable to the item dispensed on the prescription;

    (b)the name or initials of the pharmacist who dispensed the item;

    (c)the date on which the item was dispensed;

    (d)the trade name and the generic name of the item, or, if it does not have either a trade or generic name, its ingredients, and the form, strength and quantity of the item dispensed;

    (e)the name and address of the person for whose use the item was dispensed;

    (f)the directions for the safe and proper use of the item given in accordance with these regulations;

    (g)the name of the person who prescribed the item.

  2. Records kept under this regulation—

    (a)must be retained for a period of at least two years; and

    (b)must be kept at the premises at which the items to which the records relate were dispensed or at other premises approved for that purpose by the Board; and

    (c)must be readily accessible; and

    (d)must be made available for inspection at any reasonable time at the request of the Board.

  3. Where the information contained in any record is accessible only after the record is subjected to electronic or other process, it is sufficient for the purposes of this regulation for the person to produce for inspection a reproduction or computerised record of any entry in the records.

  4. If a requirement of this regulation is contravened, the person who carries on the business in relation to which the records must be kept is guilty of an offence.

    Penalty: Division 7 fine.

25—Delivery of dispensed items

  1. An item dispensed by a pharmacist on a prescription must not be given or sent to a person, or left for collection by a person, at any premises except—

    (a)registered premises; or

    (b)premises occupied by a pharmacist; or

    (c)premises occupied by the person for whose use the item is dispensed.

  2. If an item dispensed by a pharmacist on a prescription is to be given or sent to a person, or left for collection by a person, at premises other than premises occupied or supervised by a pharmacist, the item must be packaged, wrapped and addressed to the person for whose use the item is dispensed.

  3. If an item is given, sent or left for collection in contravention of this regulation, the pharmacist who dispensed the item is guilty of an offence.

    Penalty: Division 7 fine.

  4. It is a defence to a charge of an offence against this regulation if it is proved that the offence did not result from any failure on the part of the defendant to take reasonable care to avoid the commission of the offence.

26—Non-derogation from Controlled Substances Act 1984

  1. These regulations do not derogate from regulations made under the Controlled Substances Act 1984.

  2. The information required to be displayed under these regulations may be displayed on a label containing information required to be displayed under the Controlled Substances Act 1984.

Division 4—Advertising

27—Advertising by pharmacists

  1. A person must not advertise in respect of the practice of pharmacy except under the name of a registered pharmacist or a business or trading name approved by the Board.

    Penalty: Division 7 fine.

  2. A person must not advertise in respect of the practice of pharmacy—

    (a)in a manner that is likely to bring discredit on the profession of pharmacy; or

    (b)in a manner that draws invidious comparison between pharmacists or groups of pharmacists; or

    (c)in a manner that is likely to mislead.

    Penalty: Division 7 fine.

Schedule 1—Qualifications

(Regulation 5)

Part 1—Qualifications from Australia or New Zealand

School of Pharmacy, University of South Australia

Department of Pharmacy, University of Queensland
Department of Pharmacy, University of Sydney
Victorian College of Pharmacy (Monash University) Ltd.
School of Pharmacy, University of Tasmania
School of Pharmacy, Curtin University of Technology
School of Pharmacy, University of Otago, Dunedin
Central Institute of Technology, Heretaunga

Part 2—Qualifications from Ireland or Great Britain

Pharmaceutical Society of Great Britain

School of Pharmacy, University of Bath, United Kingdom
Department of Pharmacy, University of Aston in Birmingham
School of Pharmacy, Brighton Polytechnic
Welsh School of Pharmacy, University of Wales Institute of Science and Technology, Cardiff
School of Pharmacy, City of Leicester Polytechnic
School of Pharmacy, Liverpool Polytechnic
Department of Pharmacy, Chelsea College, University of London
The School of Pharmacy, University of London
University College, Dublin
Pharmacy Department, The University of Manchester
Faculty of Pure Science, University of Nottingham
School of Pharmacy, Portsmouth Polytechnic
School of Pharmacy, Sunderland Polytechnic
School of Pharmacy, Robert Gordon's Institute of Technology, Aberdeen
Department of Pharmacy, Heriot-Watt University, Edinburgh
School of Pharmaceutical Sciences, University of Strathclyde, Glasgow
Department of Pharmacy, The Queen's University of Belfast

Schedule 2—Forms

The forms included in this Schedule are to be used for the purposes indicated.

Legislative history

Notes

•For further information relating to the Act and subordinate legislation made under the Act see the Index of South Australian Statutes.

Revocation of regulations

The Pharmacists Regulations 1991 were revoked by Sch 3 of the Pharmacists Regulations 2006 on 1.9.2006.

Principal regulations

Year No Reference Commencement
1991 234 Gazette 21.11.1991 p1334 21.11.1991: r 1

Appendix—Divisional penalties and expiation fees

At the date of publication of this version divisional penalties and expiation fees are, as provided by section 28A of the Acts Interpretation Act 1915, as follows:

Division

Maximum imprisonment

Maximum fine

Expiation fee

1

15 years

$60 000

—

2

10 years

$40 000

—

3

7 years

$30 000

—

4

4 years

$15 000

—

5

2 years

$8 000

—

6

1 year

$4 000

$300

7

6 months

$2 000

$200

8

3 months

$1 000

$150

9

–

$500

$100

10

–

$200

$75

11

–

$100

$50

12

–

$50

$25

Note: This appendix is provided for convenience of reference only.

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